Chronic Pulmonary AspergillosisPhase 2NCT06794554
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
A Phase 2 study testing Rezafungin Acetate in people with Chronic Pulmonary Aspergillosis, run by Mundipharma Research Limited at 37 sites in 10 countries.
Trial summary
The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- What is being tested?
- Rezafungin Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Males or females ≥18 years of age
- Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months:
- one or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, night sweats, fever and dyspnoea)
- slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax
- immunological, microbiological or molecular evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index >0.5 or BALF galactomannan index >1), positive Aspergillus IgG, or positive PCR
Show all 14Show fewer
- exclusion of active tuberculosis or non-tuberculous mycobacterial pulmonary infection or disorders that will prevent evaluation of outcome over 6 months. Patients on anti-mycobacterial therapy can be enrolled if their mycobacterial infection is stabilised
- Unable to receive systemic azole antifungal therapy due to any of the following: documented or anticipated resistance, intolerance, contraindication (e.g. due to drug-drug interactions or organ dysfunction), inability to take oral medication, or lack of availability. NOTE: the administration of rezafungin is monotherapy only, and subjects currently on azoles who are able to remain on therapy are not eligible
- Antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms
- Female subjects of child-bearing potential <2 years post-menopausal (unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from heterosexual intercourse, or agree to use barrier contraception (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug, unless the partner is >2 years post-menopausal or otherwise sterile.
- Definitions: Woman of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- A postmenopausal state: no menses for 12 months without an alternative medical cause.
- Abstinence: refraining from heterosexual intercourse (only if it corresponds to the subject's usual lifestyle)
- Willingness to comply with all aspects and assessments required in this study
Who cannot join
- Subjects with invasive aspergillosis, aspergillus nodules, or simple aspergilloma
- Known or suspected hypersensitivity to rezafungin for Injection or any of its excipients
- Current participation in another interventional treatment trial with an investigational agent. Participation in another interventional treatment trial is permitted during the follow-up period of the study
- Recent use of an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product, whichever is greater, to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening. In some cases, use of investigational products may be acceptable in consultation with the Sponsor's Medical Monitor
- Administration of any other echinocandin or intravenous antifungal treatment within 3 months of screening
- Administration of ≥15mg prednisolone daily (or other equivalent immunosuppressant) for at least 3 weeks within 4 weeks of screening
Show all 14Show fewer
- Acute respiratory infections considered inadequately treated in the opinion of the Principal Investigator. Any subjects diagnosed with an acute respiratory infection during the screening period should be re-screened following the required course of appropriate treatment and enrolled when considered adequately treated.
- Subjects with active malignancy who are receiving chemotherapy or radiation therapy
- Severely immunocompromising conditions according to the opinion of the investigator such as bone marrow transplantation, neutropenia, or have received cancer chemotherapy within last 6 months
- Subjects on the palliative care pathway
- Any other condition or laboratory abnormality that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study
- A. Meets National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher B. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
- Planned or ongoing therapy at Screening with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher.
- Pregnant or lactating females
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
United Kingdom9 sites
Royal Papworth Hospital
Cambridge
University Hospitals of Derby and Burton
Derby
University of Dundee
Dundee
Western General Hospital
Edinburgh
Leeds Teaching Hospital
Leeds
Imperial College Hospital
London
Royal Brompton Hospital, Guy's and St. Thomas' Hospital
London
University College London (UCL) Hospitals
London
Manchester University Hospital
Manchester
Spain6 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Vall d'Hebron Barcelona Hospital Campus
Barcelona
Ramón y Cajal Hospital
Madrid
Hospital Sant Joan de Deu de Martorell
Martorell
Hospital La Fe
Valencia
Belgium4 sites
Brussels University Hospital
Brussels
UZ Gent
Ghent
University Hospital Leuven
Leuven
CHU UCL Namur
Yvoir
France4 sites
CHU Amiens Picardie
Amiens
Institut Coeur Poumon CHU
Lille
CHU Arnaud de Villeneuve
Montpellier
CHU Bordeaux
Pessac
Italy4 sites
University of Genova, San Martino Hospital
Genova
University of Pisa
Pisa
INMI Lazzaro Spallanzaniconsu
Roma
Humanitas Research Hospital
Rozzano
South Korea4 sites
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Germany3 sites
Evangelische Lungenklinik Berlin
Berlin
University of Cologne
Cologne
Asklepios Lungenfachklinik Gauting
Gauting
About this study
Official title: A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options
The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options.
The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging.
Participants will:
- Be given the drug rezafungin every week for 6 months.
- Visit the clinic once a month for checkups and tests.
- Complete questionnaires on thier health and wellbeing.
Read the detailed description
Chronic pulmonary aspergillosis (CPA) is a progressive and potentially life-threatening fungal infection of the lungs. It is usually, but not exclusively, caused by Aspergillus fumigatus and affects patients with underlying respiratory disorders with a prevalence of less than 1 per 100,000 in Europe. The disease leads to the destruction of lung tissue typified by the insidious enlargement of cavities and fibrosis which can severely impact quality of life and has a mortality of up to 14% in one year. The only approved class of oral antifungals are the azoles such as voriconazole or itraconazole. Treatment with azoles is for a minimum of six months, however, in practice can be long-term and, in some cases, lifelong.
Azole resistance can often be attributed to the suboptimal treatment response rates in CPA. This is possibly a consequence of accumulations of the Aspergillus fungus that form 'aspergillomas' which harbour high concentrations of the fungus, thus driving the propensity to develop resistance. The resistance to one azole can often be associated with pan-azole resistance resulting in a lack of effective oral treatment options.
In addition to drug resistance, azoles are potentially hepatotoxic, can elicit adrenal suppression and neuropathy. One of the main safety concerns with voriconazole is that it has been linked to skin cancer. If azole therapy is not an option due to intolerance or resistance, patients are left with Intravenous (IV) amphotericin B (which due to toxicity can only be given short-term) or IV echinocandins. Currently licensed IV echinocandins need to be given daily which limits the practicality of longer-term therapy.
This proposed study aims to generate clinical data on the efficacy and safety of rezafungin for treatment of CPA.
- Conditions
- Chronic Pulmonary Aspergillosis
- Being tested
- Rezafungin Acetate
- Keywords
- Chronic pulmonary aspergillosis, Rezafungin, Rezzayo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezafungin AcetateDrug
IV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Rezafungin for Injection, IV, with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months). Receives: Drug: Rezafungin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical and radiological response at 6 months
Participants achieving a clinical improvement and radioligical improvement by CT scans
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start30 Jun 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794554
- Sponsor's protocol ID
- MR907-2502
- Status last verified
- May 2026
- First submitted
- 26 Nov 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options
- ClinicalTrials.gov ID
- NCT06794554
- Acronym / sponsor ID
- MR907-2502
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- Chronic pulmonary aspergillosis, Rezafungin, Rezzayo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options.
The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging.
Participants will:
- Be given the drug rezafungin every week for 6 months.
- Visit the clinic once a month for checkups and tests.
- Complete questionnaires on thier health and wellbeing.
Detailed description
Chronic pulmonary aspergillosis (CPA) is a progressive and potentially life-threatening fungal infection of the lungs. It is usually, but not exclusively, caused by Aspergillus fumigatus and affects patients with underlying respiratory disorders with a prevalence of less than 1 per 100,000 in Europe. The disease leads to the destruction of lung tissue typified by the insidious enlargement of cavities and fibrosis which can severely impact quality of life and has a mortality of up to 14% in one year. The only approved class of oral antifungals are the azoles such as voriconazole or itraconazole. Treatment with azoles is for a minimum of six months, however, in practice can be long-term and, in some cases, lifelong.
Azole resistance can often be attributed to the suboptimal treatment response rates in CPA. This is possibly a consequence of accumulations of the Aspergillus fungus that form 'aspergillomas' which harbour high concentrations of the fungus, thus driving the propensity to develop resistance. The resistance to one azole can often be associated with pan-azole resistance resulting in a lack of effective oral treatment options.
In addition to drug resistance, azoles are potentially hepatotoxic, can elicit adrenal suppression and neuropathy. One of the main safety concerns with voriconazole is that it has been linked to skin cancer. If azole therapy is not an option due to intolerance or resistance, patients are left with Intravenous (IV) amphotericin B (which due to toxicity can only be given short-term) or IV echinocandins. Currently licensed IV echinocandins need to be given daily which limits the practicality of longer-term therapy.
This proposed study aims to generate clinical data on the efficacy and safety of rezafungin for treatment of CPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Rezafungin AcetateRezafungin for Injection, IV, with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent
- Males or females ≥18 years of age
- Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months:
- Unable to receive systemic azole antifungal therapy due to any of the following: documented or anticipated resistance, intolerance, contraindication (e.g. due to drug-drug interactions or organ dysfunction), inability to take oral medication, or lack of availability. NOTE: the administration of rezafungin is monotherapy only, and subjects currently on azoles who are able to remain on therapy are not eligible
- Antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms
Key exclusion criteria (14 listed)
- Subjects with invasive aspergillosis, aspergillus nodules, or simple aspergilloma
- Known or suspected hypersensitivity to rezafungin for Injection or any of its excipients
- Current participation in another interventional treatment trial with an investigational agent. Participation in another interventional treatment trial is permitted during the follow-up period of the study
- Recent use of an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product, whichever is greater, to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening. In some cases, use of investigational products may be acceptable in consultation with the Sponsor's Medical Monitor
- Administration of any other echinocandin or intravenous antifungal treatment within 3 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezafungin AcetateIV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months). | Drug | Treatment |
Primary outcome
Change from baseline in clinical and radiological response at 6 months
Time frame: 6 months
Participants achieving a clinical improvement and radioligical improvement by CT scans
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pulmonary Aspergillosis
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
Active, not recruitingObservational study
Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis
Pulmonary Tuberculoses, Chronic Pulmonary Aspergillosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rezafungin Acetate in people with Chronic Pulmonary Aspergillosis, run by Mundipharma Research Limited at 37 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United Kingdom, Spain, Belgium, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical and radiological response at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.